Gennova's mRNA vaccine gets DCGI nod to start phase-2 and 3 trials

Indigenous mRNA Covid-19 vaccine candidate, Gennova Biopharmaceuticals’ HGCO19, has got approval to start phase-2 and 3 clinical trials in the country.

If things go according to plan, the vaccine would be available in the market by the end of this year, sources said.

The Pune-based biotech firm submitted interim clinical data of the phase-1 study to the Central Drugs Standard Control Organisation (CDSCO).

The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase-I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study, a statement by the Ministry of Science & Technology said.

A multicentre, randomised, active controlled, observer blind phase-2 study followed by a phase-3 study to evaluate the safety, tolerability and immunogenicity of HGCO19 is planned. The Drugs Controller General of India (DCGI) approved the commencement of the trials.

“The study will be conducted in India at about 10-15 sites in Phase-2 and 22-27 sites in Phase-3. Gennova plans to use the DBT-ICMR clinical trial network sites for this study,” the ministry statement said.

The messenger RNA vaccine candidate contains a short, synthetic version encoding the spike protein (antigen) of the novel coronavirus Sars-CoV-2. This interacts with the receptors of host cells. When the vaccine is injected into the body, the synthetic mRNA is taken to muscle cells where it instructs the cells to make numerous copies of mRNA and the antigen. This primes the body's immune system, which learns to identify the coronavirus and protect the body when it is attacked by the actual virus.

Gennova's mRNA-based Covid-19 vaccine development program was partly funded by the Department of Biotechnology (DBT) in June 2020. Later on, the DBT further supported the program under the Mission Covid Suraksha- The Indian Covid-19 Vaccine Development Mission, implemented by BIRAC.

Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.”

Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, said that “After establishing the safety of our mRNA-based Covid-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova’s focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation's vaccine requirement.”